FDA warns Carlsbad, CA-based Premier Nutra Pharma about CGMP violations in its work as a contract drug manufacturer.
The DC federal court says FDA is correctly regulating Ipsen Biopharmaceuticals Somatuline Depot as a drug rather than as a biologic as sought by the c...
FDA clears a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, and storage of electr...
FDA accepts for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion.
FDA grants Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian cancer and endometrial ...
Two Hyman, Phelps & McNamara attorneys and a medical device regulation expert analyze a recent FDA draft guidance on artificial intelligence/machine l...
FDA approves AstraZenecas Farxiga to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in ad...
Cue Health files a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use.
